Pharmaceutical companies are looking to pediatric indications of approved adult dosage forms (ADFs) to sustain and fuel growth. The desire to develop pediatric dosage forms (PDFs) of drugs with existing adult indications has two main drivers: (1) the US Food and Drug Administration’s (FDA’s) role in limiting off-label use in pediatric patients, which aligns with the FDA’s role in ensuring the safety and efficacy of approved products for all patients; and (2) sustaining revenue growth through pediatric exclusivity that typically adds 180 days of intellectual property protection and thus almost 6 additional months of branded drug sales, which in some cases could translate to billions of dollars in revenue.

MySTYL'One members exclusive!

Quality by Design (QbD) in tablet development

can be challenging, due to the multiple competing technological aims, such as flow, compactability, lubrication and drug release. Tablets are complex and, whether due to ignorance or indeterminacy, uncertainty also makes it difficult to develop tablets robust enough to cope with scale-up and Production. Speed sensitivity of the compression mix can come as an unwelcome surprise to those who did not know that tablets have speed limits! Speed sensitivity may also be called strain rate sensitivity. The penalty for exceeding the speed limit is capping, making tablet production impossible. During development capping/lamination is unacceptable for further progression.

The paper highlights an evaluation method to determine the effect of speed during tableting on the compression properties of pharmaceutical powders (APIs mixed with excipients).

Different tests were conducted to determine viscoelasticity, stress relaxation, followed by compaction on both STYL’One compaction simulator and a rotary press. Results show that the sensitivity of the out-of-die SRS was higher than that of in-die SRS.

Full results available in the paper, head to the “Papers” section of MySTYL'One (members only).